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Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382586
Recruitment Status : Completed
First Posted : May 11, 2020
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.

Condition or disease Intervention/treatment Phase
COVID-19 Pulmonary Complications COVID-19 Drug: Zanubrutinib Drug: Supportive Care Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
Actual Study Start Date : July 6, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
 Drug: Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
Other Names:
  • BGB-3111
  • Brukinsa

Drug: Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Active Comparator: Placebo + Supportive Care
Participants received placebo plus supportive care alone
 Drug: Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator

Drug: Placebo
Placebo to match zanubrutinib


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Respiratory Failure-free Survival [ Time Frame: Up to Day 28 ]
    Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28

  2. Time to Breathing Room Air [ Time Frame: Up to 7 months ]
    Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.


Secondary Outcome Measures :
  1. Number of Participants Experiencing Respiratory Failure or Death [ Time Frame: Up to Day 28 ]
    Number of participants experiencing respiratory failure or death on or before Day 28

  2. Number of Participants With All-cause Mortality [ Time Frame: Up to Day 28 ]
    Number of participants with all-cause mortality on or before Day 28

  3. Number of Participants Discharged Alive [ Time Frame: Up to Day 28 ]
    Number of participants discharged alive on or before Day 28

  4. Number of Participants Discharged Alive From the ICU [ Time Frame: Up to Day 28 ]
    Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28

  5. Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale [ Time Frame: Up to Day 28 ]
    Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.

  6. Duration of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
    Number of days on mechanical ventilation on or before Day 28

  7. Duration of Hospitalization [ Time Frame: Up to Day 28 ]
    Number of days hospitalized on or before Day 28

  8. PaO2:FiO2 Ratio [ Time Frame: Baseline, Day 7, Day 14, Day 21 and Day 28 ]
    Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio

  9. Number of Participants With Adverse Events [ Time Frame: Up to 7 months ]
    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), and TEAEs grade 3 or higher, including laboratory findings


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Hospitalization for COVID-19 infection
  2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
  3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening

Key Exclusion Criteria:

  1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
  2. On a Bruton's tyrosine kinase (BTK) inhibitor
  3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
  4. Participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382586


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] January 8, 2021
Statistical Analysis Plan  [PDF] March 3, 2021

More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04382586    
Other Study ID Numbers: BGB-3111-219
First Posted: May 11, 2020    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BeiGene:
Corona Virus
COVID-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action